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Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)


Inclusion Criteria:



- Histologically or cytologically proven NSCLC patients

- All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest
CT and PET-CT

- 18 year of ages or older

- ECOG performance status 0-1

- Uni-dimensionally measurable lesion by RECIST criteria

- No prior chemotherapy or radiotherapy for NSCLC

- Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days

- Adequate bone marrow function: Hb > 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥
100,000/μL

- Adequate liver and renal function: Total bilirubin < 2 x ULN, AST/ALT < 3 x ULN,
serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min

- Written informed consent

Exclusion Criteria:

- Superior sulcus tumor

- Prior malignancy except for adequately treated basal cell or squamous cell skin
cancer or in situ cervical cancer at least 5 years

- Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia

- Recent myocardial infarction within 6 months

- Patients with post-obstructive pneumonia or serious infection

- Pregnant or nursing women (Women of reproductive potential have to agree to use an
effective contraceptive method.)

- Patients with psychological problem

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year disease-free survival

Principal Investigator

Keunchil Park, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2004-09-027

NCT ID:

NCT00329472

Start Date:

April 2006

Completion Date:

July 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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